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Gibeck IPN043751

by Teleflex Incorporated

Ref 19212

Gibeck IPN043751 (19212) is a device classified as Class IIa in the EU and Class II in the US made by Teleflex Incorporated, registered in EUDAMED on 31 Jul 2026 (Basic UDI-DI B-04026704348008), cleared under FDA 510(k) K965016 on 2 Dec 1997 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04026704348008), active as of 24 Oct 2026. 6 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

6 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K965016

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04026704348008 Basic UDI-DI 04026704348008UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026704348008 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK965016 Date2 Dec 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04026704348008 registered 31 Jul 2026 Active
  • FDA 510(k) K965016 decided 2 Dec 1997 Active
  • FDA GUDID UDI-DI 04026704348008 listed 16 Sep 2016 Listed

Recalls

6 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-0073-2023 FDA Class I initiated 29 Aug 2022
    • Ongoing Z-0074-2023 FDA Class I initiated 29 Aug 2022
    • Ongoing Z-0075-2023 FDA Class I initiated 29 Aug 2022
    • Ongoing Z-0072-2023 FDA Class I initiated 29 Aug 2022
    • Ongoing Z-0077-2023 FDA Class I initiated 29 Aug 2022
    • Ongoing Z-0076-2023 FDA Class I initiated 29 Aug 2022

    Incidents of device splitting or detaching during use

Timeline

9 dated events

  1. Cleared FDA 510(k) K965016
  2. Listed FDA GUDID 04026704348008
  3. Recall initiated FDA recalls Z-0073-2023
  4. Recall initiated FDA recalls Z-0074-2023
  5. Recall initiated FDA recalls Z-0075-2023
  6. Recall initiated FDA recalls Z-0072-2023
  7. Recall initiated FDA recalls Z-0077-2023
  8. Recall initiated FDA recalls Z-0076-2023
  9. Registered EUDAMED B-04026704348008

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Iso Gard Filter S EUDAMED
Gibeck GUDID
Generic name
Microbial medical gas filter, single-use
Device name
Iso-Gard Filter,straight
Model / Ref / Catalog
19212, IPN043751
Primary DI / UDI-DI
04026704348008
Basic UDI-DI
B-04026704348008
510(k) Number
FDA product code
CAH
EMDN code
R040101 Antibacterial and antiviral respiratory filters
GMDN term
Microbial medical gas filter, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5260
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
19212
GUDID
IPN043751
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Microbial medical gas filter, single-use

Cleared under the same submission (K965016)

Similar devices in this category

Other devices filed under ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS.

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    Class II

  • Arrow IPNB00826 Open recall

    Class II

  • Arrow IPNB00822 Open recall

    Class II

  • Arrow IPNB00827 Open recall

    Class II

See all devices from Teleflex Incorporated →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)